Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07215949

Zilucoplan for Severe gMG Exacerbations

Led by Miriam Freimer · Updated on 2026-02-23

15

Participants Needed

1

Research Sites

114 weeks

Total Duration

On this page

Sponsors

M

Miriam Freimer

Lead Sponsor

U

UCB Pharma

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is an open-label, multicenter, interventional phase 3b study in participants with AChR+ gMG and severe exacerbation that require hospitalization. Patients will receive subcutaneous zilucoplan injections daily for 12 weeks. Participation in the study will last for approximately 18 weeks.

CONDITIONS

Official Title

Zilucoplan for Severe gMG Exacerbations

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Severe myasthenia gravis exacerbation requiring hospitalization, with bulbar and/or respiratory symptoms or neck extension weakness
  • MGFA class II to IVb
  • Male or female aged 18 years or older
  • MG-ADL score of 6 or higher in non-ocular domains
  • Positive acetylcholine receptor antibody test (AChR+) or historically documented positive result
  • Negative serum pregnancy test for women of child-bearing potential
  • Willingness to use acceptable birth control methods during the study and for 40 days after last dose for women of child-bearing potential and men with partners of child-bearing potential
  • Completed or started meningococcal vaccination with appropriate antibiotic prophylaxis as per guidelines
Not Eligible

You will not qualify if you...

  • History of meningococcal disease
  • Requirement for intubation before starting the study
  • Recent serious infections causing exacerbation, such as sepsis or wound infections
  • Pregnancy or breastfeeding
  • Surgery within 4 weeks before the study (minor procedures allowed at investigator's discretion)
  • Use or known failure of C5 inhibitors within the past 3 months
  • Plasma exchange or IVIG started within the past 4 weeks
  • Participation in another clinical trial with a therapeutic drug
  • Rituximab treatment within the past 9 months
  • Any other significant illness or condition posing risk or confounding the study as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

J

Julie Agriesti, MACPR, CCRC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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